As a direct result of the public meltdown over antidepressant medications for teens, pharmaceutical companies have come under pressure to open their trial data to public scrutiny from both the public and the medical establishment. Editors of medical journals, long regarded as the quality control engineers of the profession, have begun to require that companies publicly register drug trials at the outset as a prerequisite for journal publication, which would deter drug manufacturers from hiding the results of failed tests.
And public entities are attacking the drug companies, as well. In June 2004, New York State attorney general Eliot Spitzer accused Paxil’s manufacturer GlaxoSmithKline of highlighting only the positive results of its clinical trials, while burying either inconclusive or negative results. While denying any wrongdoing, GlaxoSmithKline settled the state’s case for $2.5 million in August 2004 and agreed to post test results in a comprehensive drug trial database (www.clinicaltrials.gov). Shortly thereafter, Eli Lilly, Prozac’s manufacturer, followed suit. Both companies insist that all trial data will be published by the end of 2005. Other pharmaceutical manufacturers will follow suit or risk public condemnation. As Dr. Peter Honig, senior vice president of the pharmaceutical giant Merck, lamented, “Let’s face it, the perceptions of the pharmaceutical industry as a whole are not healthy at this moment.19
Senator Edward M. Kennedy, a senior member of the Senate’s committee on health, suggests that legislation needs to be enacted to force the industry into greater transparency, because “voluntary measures by companies, while generally laudable, will not produce the comprehensive information the public needs and deserves to assess the safety and effectiveness of the medicines they take.”20 We want an industry whose research is unbiased and indisputably working in the interest of humankind. It may be too much to expect, but as Dr. Marcia Angell writes in her tome, The Truth About Drug Companies (Random House, August 2004), “Despite all its excesses, this is an important industry that should be saved—mainly from itself.”21
Ultimately, whose job is it to ensure that our children are free from harm resulting from poor medical decision-making? Given current industry regulations, and an abysmal track record, the drug companies cannot be relied upon to provide responsible guarantees of safety or efficacy. Does it fall to the doctors and clinicians in whom we place our trust to “first do no harm”? Or our lawmakers, whose hefty reliance upon the pharmaceutical industry for campaign funding casts doubt on their objectivity to act in the best interest of the public? Or is it the responsibility of a public, taxpayer-supported FDA, whose mandate is to safeguard the public health and offer timely and critical advice to parents, patients, and caregivers, untainted by perceptions of industry bias?
In September 2004 the FDA once more convened the advisory panel to review the results of the Columbia University study of previously examined trial data. By that time the FDA was mired in two separate congressional investigations initiated by families of depressed teens, who alleged that senior officials at the FDA mishandled the internal research provided to the advisory committee in an effort to skew the panel’s recommendations in favor of the drug companies; the FDA denied the charge. The public mistrust of the FDA, along with the pharmaceutical industry, was running high.
Once more, the meetings were overshadowed by the anguished stories of grief and loss from families who had lost children to suicide while in treatment with antidepressants. Once again, the members of the advisory panel were excoriated for “having the blood of children” on our hands. It was traumatizing enough to sit through the hearings in February 2004; repeating the experience six months later was no easier.
The advisory panel was asked to sort out the next steps for the FDA. The FDA’s Dr. Thomas Laughren once again summarized the debate: “While there remains a signal of risk for suicidality in some drugs and some trials, it is important to note that the data are not ‘black and white’ in providing a clear and definitive answer to the question of a link between the drugs and pediatric suicidality.”22
At the hearing’s conclusion, the advisory panel moved to urge more comprehensive labeling in the form of a “black box” warning to be placed on all antidepressant medication, and asked that the FDA provide more detailed information to guide physicians, families, and patients whenever a prescription for an antidepressant is written. They stopped short of calling for a ban on SSRIs and other antidepressants and pressed for more government-funded independent clinical trials.
On October 15, 2004, the FDA called on all manufacturers of antidepressant drugs to post black box warnings highlighting the medications’ risks on their products. Along with the black box label, patients will be provided with a “med guide” outlining the drugs’ risks and requirements for careful monitoring. Dr. Lester M. Crawford, acting FDA Commissioner announced, “Our conclusions are based on the latest and best science. They reflect what we heard from our advisory committee last month, as well as what many members of the public have told us.”23 I agree that the strenuous warning reflects the majority opinion of the advisory committee, but it’s more than a tad disingenuous to state that the FDA’s process for reviewing drug safety represents “best science.” After participating directly in the process as an advisory committee member, I can attest that the atmospherics of the large public forum, with its mix of grieving families and anti-psychiatry flamethrowers, trumped any possibility of rigorous scientific debate. But the one clear message we heard from the audience at the September hearing was the more information parents get, the better—even if it comes, lamentably, in the form of a black box warning.
So now the brakes are on and only time will tell if these latest warnings will help or hinder patients. I feel certain that doctors will no longer prescribe these drugs with the indifference to patient diagnoses and proper care evinced over the past few years. If even a small number of children are spared because of the FDA’s dire black-box warning, then we have accomplished a laudable goal. If, however, parents or treating physicians of hundreds of thousands of kids steer clear of antidepressants out of fear of triggering suicidal thinking, then we are putting the millions of young people suffering horrifically from depression at grave risk.*
At the 2004 annual meeting of the American Academy of Child and Adolescent Psychiatry, Dr. David Shaffer reported that two as of yet unpublished studies of adolescent suicides showed no trace of SSRIs in the toxicology reports of an overwhelming majority of the teens who took their own lives.24 Is it possible that there is no causal link between antidepressants and the depressed kids who managed to kill themselves? Had they been on medication and simply stopped taking the drugs prior to the time of their deaths? Will these data help resolve the safety issue in the near future?
As I have said before, depression is a life-threatening illness, and as any parent of a depressed or emotionally troubled child will tell you, access to reliable information about possible remedies and treatment options takes on urgency proportional to the degree of your child’s suffering. Parents need as much information as they can get their hands on, and they need to be able to access it quickly.
In an effort to stem the public’s loss of confidence and on the heels of two separate congressional investigations critical of the agency’s drug review process, the FDA announced on November 5, 2004, that it would strengthen the system for reviewing drug safety. Dr. Steve Galson, director of the FDA’s Center for Drug Evaluation and Research allowed, “Our current drug approval system has demonstrated that we don’t always understand the full magnitude of drug risks prior to approval of drug products.”25 What an understatement! In an effort to reform the process, the Institute of Medicine (an arm of the National Academy of Sciences) was hired to investigate the FDA’s drug approval mechanisms. I would suggest nothing short of a complete overhaul establishing a permanent and independent body that somehow untangles the influence of the pharmaceutical companies from the mission of the regulatory agency.
Until the FDA concludes a comprehensive and independen
t review of all the data related to both efficacy and risk, the debate over antidepressants for young people will continue to draw fire and stir the misgivings of a conflicted public. And, until the medical establishment, our government, and the insurance industry treat psychiatric illnesses as seriously as they treat physical illnesses, parents of sick children will be whipsawed by the controversy. They will be forced to wade through contradictory data and calculate the risks and benefits of antidepressants on their own. As I can attest, this is an unforgiving position to be in—especially if you are the parent who makes the wrong decision.
One day in early August 2001, I was talking to Will’s psychiatrist, Dennis Malinak, about the latest change in Will’s medication, and we had a collective brainstorm.
“Dennis, you know, I’ve just switched to a new antidepressant. I’m on Celexa and I’m taking it in conjunction with Concerta. But I still take Remeron at night.”
“Right—that’s the latest in combination drug therapies. People are calling it ‘California Rocket Fuel’ yeah, some doctors in California have been trying it in some really impenetrable cases of depression—with good results.”
“Would it make sense, do you think, to try Will on this combination? We probably share some of the same genes, would it work the same way on him?” I asked.
“Makes sense to me,” he replied, and quickly adjusted Will’s pharmacological cocktail. We started seeing improvements in Will almost immediately. Over the next month, as Will continued a sustained recovery, ECT was taken off the table as a possible treatment option.
Bob’s letter to Will, from Arcata, California:
August 4, 2001
Hey, man—
I’m up in the town of Arcata, California spending the weekend with our friends Sheila and H.G…. It’s a foggy, quite beautiful region right on the coast with a great many redwood forests near-by, which is this area’s chief claim to fame. Naturally, there are thousands, perhaps millions of teenagers and twenty-somethings flocking up here to get their fill of the natural wonders of mountain and coast.
Another week gone. Hope you’re doing well. Got a report from your mom that you had done a bit of rock climbing and some sort of downhill sports last weekend that she didn’t fully understand. Apparently this was the reward for kids who had done particularly well on the most recent round of grades. So, congrats for winning the extra getaway. Hope it was fun. I’d love to hear a bit of what the rock climbing was like. Were you doing ropes and the likes? What kind of rock faces did you tackle? Was it difficult? I’ve never done actual climbing with ropes. I remember a few times as a kid taking on simple rock faces where you would try to make it up as far as you could go—or as far as you could keep your nerve before turning back. I remember getting myself into some places where I wasn’t sure how to move either higher or how to turn back without killing myself. Although, obviously, I never did fall. I’m sure if I were back in those same places, I would see that there was never any real danger involved. But my youthful imagination made it seem pretty scary. Or, who knows? Maybe there were some precarious spots. Sometimes I watch kids doing things that, by all rights, they should never survive. Sometimes it’s nothing more than jaywalking with reckless abandon through fast-moving traffic. It’s a miracle that any kid survives. I’m sure I put myself in such situations growing up.
Word has it that the changes in your meds are leaving you feeling at least a little less tired—if not yet truly relieved of the heavy depression. I’m hoping that the latter will occur before long. It will happen someday. Keep remembering that. I know that Dennis tells you and probably everyone else. But we’re not going to settle for anything less than you feeling okay with the world. You deserve no less, and I am absolutely confident that the day will come. Thinking of you.
Love,
Dad
Will’s letter to Bob, early August 2001:
Dad…
Hey big guy. Sorry it took a long time to write. I’ve been really busy. Really tired and depressed and such. I’m actually feeling a little bit better. Possibly new meds. Lord only knows. Camping trip was slightly fun, slightly tedious, slightly boring as hell.
Movie night tonight. Watching “Coyote Ugly” (previously viewed at PIW). Never actually gotten all the way through it, or started watching it for that matter.
Letter from Megan wasn’t necessarily breaking up. All very uncertain. We’ll have to wait and see. I’ll talk to you soon. And make a conscious effort to write more (no sarcasm).
Love,
Will
My letter to Will, from Washington, D.C.:
August 13
Dearest Woo,
Well, today I got yet another letter from you—the one about the Invasion of the Cow People and the mysterious crapper. Now you’re on a roll. Keep ’em coming.
We’re taking John to school next week on August 22nd. He’s really excited about our being there to help him move into the dorm (not).
I’m sending you (you know I’ve always loved you best) my treasured collection of exotic envelopes from former Communist regimes. I would never have parted with these under any circumstances before now, but I know you’re the right guy to know what to do with them.
Jack ran into Vic at Home Depot’s hot dog stand—he says he’s just a working fool this summer—two jobs.
Jane goes back to Charleston on the weekend and then we have no kids at home—weird! I’m trying to convince Jack to buy me a pet Iguana—something troublesome and scaly, so I won’t miss those other children. He figures now he’ll be able to wear his Lycra bike outfits around the house all of the time.
I love you. I love you—and I get to see you in two weeks.
Mom
Will’s letter to me, from Marion, Montana:
August 17, 2001
Mom…
Well, not much here. School’s almost over. Enjoying the benefits of Sun Clan. Haven’t really seen too many of those benefits yet. I’m sure they’re on their way. Get to go to movies on Monday because we celebrate the graduates and such. Haven’t actually started writing friends yet. Could you send addresses for Vic, Henry, John and anyone else you can think of?
How’s Max’s tattoo coming? Alice mentioned something about it in one of her letters. I figure your opinion/description was probably a bit tainted. Have to wait and see for myself. Am actually quite relieved to get my new phase. I can have music now. I’ll write to Max and tell him to make me some tapes. I’ll probably ask him about the tattoo so as to acquire a completely unbiased interpretation. Say “hi” to my buddies in the office. Tell them they can write. I’m sure they’ve been holding their breath.
Love,
Will
In late August, Bob, Melissa, Jack, Max, and I spent the Labor Day holiday with Will exploring Glacier National Park. A forest fire raged out of control at the west end of the park, and as we drove north and east through the Rocky Mountains, over Logan’s Pass at the summit, we could see vast swaths of lavender smoke from the forest fire hanging over the lakes and valleys, producing the most extraordinary visual plays of light and color I have ever seen. Will took pictures and Max made lewd jokes and posed for a photo in front of the National Park Service sign announcing LOGAN PASS, positioning his body so that he covered the AN and P to spell LOG…ASS, producing the trip’s greatest piece of pictorial memorabilia. Max and Will thought it hilarious.
As we pulled into the historic Glacier Park Lodge, an imposing granite chalet at the northern end of the park near the Canadian border, it rained ash from the fires and our eyeballs and nostrils were stung by the acrid smell of the burn.
The fires died down and we went white-water rafting on the Flathead River and canvassed the region for the best homemade pies. Everyone, including Will, had a wonderful time. The trip provided all of us a brief respite from the focus on Will’s troubles and reminded us of better times. And, best of all, Will seemed measurably better.
Letter to Will from my mom, Duff Griffith, en route to Tianjin,
China, by freighter:
August 21, 2001,
Dearest Willy,
First of all, this is not The Good Ship Lollipop. Nor is this a “sweet trip.” And the next time I think about going around the world, I’ll jump on the Tijuana Trolley, get off in Tijuana and drink Margaritas until the thought passes.
You probably have the only grandmother at Montana Academy who is on Pirate Watch. It used to be we would only be on Pirate Watch for a few days going through the Malacca Straits, but now you have to have everything locked up and lights off from the time you get through the Red Sea to Singapore. They [pirates] are more vicious and numerous. They even hijack ships, which aren’t exactly concealable like a diamond ring or a pigskin wallet. On top of all this idiocy we have been on the ship, without getting off for eighteen days and yesterday we docked in Jakarta to unload God Knows What and pick up a load of God Knows What for Houston. But the State Department put out an official warning: No Americans should disembark in Jakarta, as leftist terrorists are out to get Americans. So we stood around and looked at Jakarta from the deck and I must admit I wasn’t thrilled with what I saw and over it all hangs a pall of wood smoke–like smog.
But tomorrow we land in Singapore, which is one of my favorite spots in the whole wide world. You can walk all over the place anytime day or night safely, but God help you if you chew gum. It’s my kind of town. We plan to buy newspapers, books (we are down to one 1965 Reader’s Digest condensation and one 1997 Time Magazine. Also we are going to buy beaucoup packages of cookies and candies. I’ll try to call your mom and [your aunt] Suzy…but sometimes it doesn’t work out.
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